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Hearing for Communication and Resident Engagement

HearCARE: Hearing for Communication and Resident Engagement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04575051
Acronym
HearCARE
Enrollment
684
Registered
2020-10-05
Start date
2021-06-01
Completion date
2023-11-01
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Age-Related

Keywords

hearing loss, communication, social participation

Brief summary

Amplification is a well-established, evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults. The challenge in treating ARHL is identifying a care model that effectively promotes adherence to individualized-treatment recommendations allowing the end-user to self-manage hearing loss with appropriate support. This proposal compares the two most common models of care for ARHL provided to adults in assisted living/personal care communities. The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility. The Engage Model is a chronic care approach to support hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.

Detailed description

The study is employing an open cohort stepped-wedge cluster randomized design with a phased, randomized roll out. The stepped wedge design is a useful design for the evaluation of complex health care interventions particularly when the intervention is believed to be beneficial with minimal risk. This design is increasingly being used to evaluate interventions involving health care delivery and has several advantages: 1. allowing the clinical teams to roll out the intervention in a small number of facilities in a timely, systematic manner (interventions are not part of the research protocol) 2. possibly increasing participation and buy-in since all facilities will eventually implement the intervention during the study 3. possible increase in statistical power compared to a cluster randomized trial due to increase in data collection and within cluster comparisons. Our intervention is applied at the facility level (cluster) but the primary outcomes are obtained at the resident level. In this open cohort design, all residents in a facility are identified to participate but some may leave the facility and others will move into the facility over the course of the study. The interventions are standard care at UPMC and are at the facility and individual level regardless of participation in the research project by any individual. The 10 facilities participating in the study all currently receive the Consult Model of care. These same facilities are targeted to receive the Engage Model of care over the next three years as part of the standard care in these facilities. Residents enrolled in the study during any time period will be followed until the end of the study or until they are no longer a resident of the facility, whichever comes first. This implies that crossover to the intervention is not only at the facility level but also the resident level. Once the intervention is available at a facility, residents will be exposed to the intervention continuously regardless of enrollment for the study measures. The resident level outcomes of satisfaction with social participation and hearing-specific HRQoL will be measured every 5 months for the duration of the study. In addition, staff satisfaction and family burden will be surveyed every 5 months. NOTE: The clinicaltrials.gov record was updated after data collection ended to correct the study arms and interventions. The study arms were originally and incorrectly documented in clinicaltrials.gov as the resident, caregiver, and staff cohorts rather than the interventions.

Interventions

OTHERConsult Model

The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.

OTHEREngage Model

The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

The data collectors will be masked to which phase the facility is in.

Intervention model description

Open cohort stepped-wedge cluster randomized design with a phased, randomized roll out

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Willingness to participate and * Being a resident, staff member or family member of a resident at one of the participating Assisted Living/Personal Care Facilities.

Exclusion criteria

* Unwillingness to participate * Not being a Resident, staff member or family member of a resident at one of eight Assisted Living/Personal Care Facilities.

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction With Social ParticipationBaseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) monthsPROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10).
Hearing-Specific Health-Related Quality of LifeBaseline, at 5, 10, 15, 20 and 25 monthsHearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation.

Secondary

MeasureTime frameDescription
Family BurdenBaseline, at 5, 10, 15, 20 and 25 monthsZarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden.
Staff SatisfactionBaseline, at 5, 10, 15, 20 and 25 monthsMichigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction.

Countries

United States

Participant flow

Recruitment details

The study was an open cohort stepped wedge design with continuous recruitment and enrollment. Residents were enrolled at Time Period 0 but could be enrolled at any time period of the study due to being a new resident of the facility or being interested at the time period they were approached. The protocol enrollment reflects the total number enrolled at all 10 facilities across 6 time points (Time Periods 0-5).

Pre-assignment details

Available family members of residents in the study and staff in the facilities were asked to complete surveys for the secondary outcomes during each data collection period. These individuals were not tracked across time periods or documented for lost-to-follow-up or discontinuation from the study. The number of surveys and the corresponding results are presented in the secondary outcomes. No adverse event data were required to be collected for family members and staff.

Participants by arm

ArmCount
Group 1 (HearCARE Start T1)
Participants in these facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.
162
Group 2 (HearCARE Start T2)
Participants in these facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.
133
Group 3 (HearCARE Start T3)
Participants in these facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.
165
Group 4 (HearCARE Start T4)
Participants in these facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.
123
Group 5 (HearCARE Start T5)
Participants in these facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
101
Total684

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Time Period 0Discontinued due to death or moving to higher level of care1561998
Time Period 1Discontinued due to death or moving to higher level of care131491514
Time Period 1Missing follow up13132
Time Period 2Discontinued due to death or moved to higher level of care15820158
Time Period 2Missing follow up18701
Time Period 3Discontinued due to death or moved to higher level of care541133
Time Period 3Missing follow up86430
Time Period 4Discontinued due to death or moved to higher level of care23919
Time Period 4Missing follow up173421
Time Period 5Missing follow up11812311

Baseline characteristics

CharacteristicGroup 1 (HearCARE Start T1)Group 2 (HearCARE Start T2)Group 3 (HearCARE Start T3)Group 4 (HearCARE Start T4)Group 5 (HearCARE Start T5)Total
Age, Continuous89.3 years
STANDARD_DEVIATION 7.8
87.8 years
STANDARD_DEVIATION 7.1
87.3 years
STANDARD_DEVIATION 8.3
89.0 years
STANDARD_DEVIATION 8.4
83.8 years
STANDARD_DEVIATION 8.6
87.7 years
STANDARD_DEVIATION 8.2
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
161 Participants133 Participants165 Participants123 Participants101 Participants683 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Hearing Handicap Inventory at Enrollment8.2 units on a scale
STANDARD_DEVIATION 9.2
9.0 units on a scale
STANDARD_DEVIATION 9
8.6 units on a scale
STANDARD_DEVIATION 8.9
8.0 units on a scale
STANDARD_DEVIATION 9.5
6.5 units on a scale
STANDARD_DEVIATION 8.4
8.2 units on a scale
STANDARD_DEVIATION 9
PROMIS Participation at Enrollment49.4 T-score
STANDARD_DEVIATION 7.1
50.6 T-score
STANDARD_DEVIATION 8.1
49.9 T-score
STANDARD_DEVIATION 8.8
48.1 T-score
STANDARD_DEVIATION 7.2
49.8 T-score
STANDARD_DEVIATION 7.3
49.6 T-score
STANDARD_DEVIATION 7.8
Pure tone average left side43.6 decibels
STANDARD_DEVIATION 14.8
47.3 decibels
STANDARD_DEVIATION 15.8
44.1 decibels
STANDARD_DEVIATION 17
47.0 decibels
STANDARD_DEVIATION 14.9
40.7 decibels
STANDARD_DEVIATION 14.3
44.3 decibels
STANDARD_DEVIATION 15.6
Pure tone average right side43.5 decibels
STANDARD_DEVIATION 14.2
47.0 decibels
STANDARD_DEVIATION 15.8
44.1 decibels
STANDARD_DEVIATION 17.5
47.6 decibels
STANDARD_DEVIATION 17
39.5 decibels
STANDARD_DEVIATION 14
44.0 decibels
STANDARD_DEVIATION 15.9
Race/Ethnicity, Customized
Not Reported
3 participants7 participants2 participants5 participants9 participants26 participants
Race/Ethnicity, Customized
Not White
4 participants6 participants3 participants2 participants0 participants15 participants
Race/Ethnicity, Customized
White
155 participants120 participants160 participants116 participants92 participants643 participants
Region of Enrollment
United States
162 participants133 participants165 participants123 participants101 participants684 participants
Sex: Female, Male
Female
123 Participants96 Participants126 Participants89 Participants61 Participants495 Participants
Sex: Female, Male
Male
39 Participants37 Participants39 Participants34 Participants40 Participants189 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
25 / 16223 / 13353 / 16520 / 12324 / 101
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Hearing-Specific Health-Related Quality of Life

Hearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation.

Time frame: Baseline, at 5, 10, 15, 20 and 25 months

Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of LifeBaseline (Time 0)10.2 score on a scaleStandard Deviation 11.2
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of Life5 months (Time 1)9.4 score on a scaleStandard Deviation 9.6
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of Life10 months (Time 2)8.9 score on a scaleStandard Deviation 8.8
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of Life15 months (Time 3)7.3 score on a scaleStandard Deviation 8.9
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of Life20 months (Time 4)6.9 score on a scaleStandard Deviation 8.3
Group 1 (HearCARE Start at T1)Hearing-Specific Health-Related Quality of Life25 months (Time 5)9.0 score on a scaleStandard Deviation 11
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of Life20 months (Time 4)8.5 score on a scaleStandard Deviation 8.3
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of Life25 months (Time 5)8.5 score on a scaleStandard Deviation 10
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of LifeBaseline (Time 0)10.6 score on a scaleStandard Deviation 9.6
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of Life10 months (Time 2)11.6 score on a scaleStandard Deviation 10.2
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of Life15 months (Time 3)9.8 score on a scaleStandard Deviation 10
Group 2 (HearCARE Start at T2)Hearing-Specific Health-Related Quality of Life5 months (Time 1)10.9 score on a scaleStandard Deviation 10.1
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of Life15 months (Time 3)9.5 score on a scaleStandard Deviation 9.2
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of Life20 months (Time 4)7.9 score on a scaleStandard Deviation 7.7
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of LifeBaseline (Time 0)9.2 score on a scaleStandard Deviation 10.2
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of Life10 months (Time 2)8.9 score on a scaleStandard Deviation 8.5
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of Life5 months (Time 1)9.4 score on a scaleStandard Deviation 9.2
Group 3 (HearCARE Start at T3)Hearing-Specific Health-Related Quality of Life25 months (Time 5)4.4 score on a scaleStandard Deviation 5
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of Life15 months (Time 3)10.1 score on a scaleStandard Deviation 9.5
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of Life5 months (Time 1)9.2 score on a scaleStandard Deviation 10.9
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of Life10 months (Time 2)9.2 score on a scaleStandard Deviation 9
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of Life25 months (Time 5)6.9 score on a scaleStandard Deviation 8.5
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of Life20 months (Time 4)9.7 score on a scaleStandard Deviation 8.9
Group 4 (HearCARE Start at T4)Hearing-Specific Health-Related Quality of LifeBaseline (Time 0)7.5 score on a scaleStandard Deviation 8.9
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of Life20 months (Time 4)7.0 score on a scaleStandard Deviation 8.8
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of Life10 months (Time 2)5.6 score on a scaleStandard Deviation 7
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of Life5 months (Time 1)8.9 score on a scaleStandard Deviation 9.1
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of Life25 months (Time 5)5.6 score on a scaleStandard Deviation 8.6
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of Life15 months (Time 3)6.7 score on a scaleStandard Deviation 8.5
Group 5 (HearCARE Start at T5)Hearing-Specific Health-Related Quality of LifeBaseline (Time 0)8.1 score on a scaleStandard Deviation 9.4
Comparison: The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.p-value: 0.9595% CI: [-1.13, 1.1]Mixed Models Analysis
Primary

Satisfaction With Social Participation

PROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10).

Time frame: Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months

Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (HearCARE Start at T1)Satisfaction With Social ParticipationBaseline (Time 0)49.7 T-scoreStandard Deviation 7.9
Group 1 (HearCARE Start at T1)Satisfaction With Social Participation5 months (Time 1)49.7 T-scoreStandard Deviation 7.8
Group 1 (HearCARE Start at T1)Satisfaction With Social Participation10 months (Time 2)48.1 T-scoreStandard Deviation 7.1
Group 1 (HearCARE Start at T1)Satisfaction With Social Participation15 months (Time 3)52.0 T-scoreStandard Deviation 7.1
Group 1 (HearCARE Start at T1)Satisfaction With Social Participation20 months (Time 4)49.4 T-scoreStandard Deviation 5.6
Group 1 (HearCARE Start at T1)Satisfaction With Social Participation25 months (Time 5)49.1 T-scoreStandard Deviation 7.3
Group 2 (HearCARE Start at T2)Satisfaction With Social Participation20 months (Time 4)49.0 T-scoreStandard Deviation 7.1
Group 2 (HearCARE Start at T2)Satisfaction With Social Participation25 months (Time 5)48.2 T-scoreStandard Deviation 7.8
Group 2 (HearCARE Start at T2)Satisfaction With Social ParticipationBaseline (Time 0)52.8 T-scoreStandard Deviation 8.9
Group 2 (HearCARE Start at T2)Satisfaction With Social Participation10 months (Time 2)47.6 T-scoreStandard Deviation 6.1
Group 2 (HearCARE Start at T2)Satisfaction With Social Participation15 months (Time 3)47.1 T-scoreStandard Deviation 6.5
Group 2 (HearCARE Start at T2)Satisfaction With Social Participation5 months (Time 1)48.4 T-scoreStandard Deviation 6.7
Group 3 (HearCARE Start at T3)Satisfaction With Social Participation15 months (Time 3)45.4 T-scoreStandard Deviation 6.2
Group 3 (HearCARE Start at T3)Satisfaction With Social Participation20 months (Time 4)47.2 T-scoreStandard Deviation 6.3
Group 3 (HearCARE Start at T3)Satisfaction With Social ParticipationBaseline (Time 0)51.2 T-scoreStandard Deviation 10.3
Group 3 (HearCARE Start at T3)Satisfaction With Social Participation10 months (Time 2)49.4 T-scoreStandard Deviation 7
Group 3 (HearCARE Start at T3)Satisfaction With Social Participation5 months (Time 1)47.6 T-scoreStandard Deviation 8.7
Group 3 (HearCARE Start at T3)Satisfaction With Social Participation25 months (Time 5)49.6 T-scoreStandard Deviation 8.2
Group 4 (HearCARE Start at T4)Satisfaction With Social Participation15 months (Time 3)49.9 T-scoreStandard Deviation 8.1
Group 4 (HearCARE Start at T4)Satisfaction With Social Participation5 months (Time 1)48.1 T-scoreStandard Deviation 5.6
Group 4 (HearCARE Start at T4)Satisfaction With Social Participation10 months (Time 2)48.6 T-scoreStandard Deviation 7
Group 4 (HearCARE Start at T4)Satisfaction With Social Participation25 months (Time 5)47.4 T-scoreStandard Deviation 7.2
Group 4 (HearCARE Start at T4)Satisfaction With Social Participation20 months (Time 4)48.1 T-scoreStandard Deviation 6.8
Group 4 (HearCARE Start at T4)Satisfaction With Social ParticipationBaseline (Time 0)49.4 T-scoreStandard Deviation 6.6
Group 5 (HearCARE Start at T5)Satisfaction With Social Participation20 months (Time 4)48.2 T-scoreStandard Deviation 6.4
Group 5 (HearCARE Start at T5)Satisfaction With Social Participation10 months (Time 2)47.4 T-scoreStandard Deviation 6
Group 5 (HearCARE Start at T5)Satisfaction With Social Participation5 months (Time 1)48.1 T-scoreStandard Deviation 7
Group 5 (HearCARE Start at T5)Satisfaction With Social Participation25 months (Time 5)48.9 T-scoreStandard Deviation 6.7
Group 5 (HearCARE Start at T5)Satisfaction With Social Participation15 months (Time 3)48.4 T-scoreStandard Deviation 6.6
Group 5 (HearCARE Start at T5)Satisfaction With Social ParticipationBaseline (Time 0)51.7 T-scoreStandard Deviation 7.6
Comparison: The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.p-value: 0.5895% CI: [-1.1, 1.96]Mixed Models Analysis
Secondary

Family Burden

Zarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden.

Time frame: Baseline, at 5, 10, 15, 20 and 25 months

Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (HearCARE Start at T1)Family BurdenBaseline (Time 0)5.5 score on a scaleStandard Deviation 3.7
Group 1 (HearCARE Start at T1)Family Burden5 months (Time 1)3.6 score on a scaleStandard Deviation 2.8
Group 1 (HearCARE Start at T1)Family Burden10 months (Time 2)3.9 score on a scaleStandard Deviation 2.8
Group 1 (HearCARE Start at T1)Family Burden15 months (Time 3)5.1 score on a scaleStandard Deviation 3.7
Group 1 (HearCARE Start at T1)Family Burden20 months (Time 4)4.8 score on a scaleStandard Deviation 2.8
Group 1 (HearCARE Start at T1)Family Burden25 months (Time 5)5.1 score on a scaleStandard Deviation 2.7
Group 2 (HearCARE Start at T2)Family Burden20 months (Time 4)3 score on a scaleStandard Deviation 2.8
Group 2 (HearCARE Start at T2)Family Burden25 months (Time 5)4.3 score on a scaleStandard Deviation 4
Group 2 (HearCARE Start at T2)Family BurdenBaseline (Time 0)4.4 score on a scaleStandard Deviation 3.4
Group 2 (HearCARE Start at T2)Family Burden10 months (Time 2)6.7 score on a scaleStandard Deviation 4.4
Group 2 (HearCARE Start at T2)Family Burden15 months (Time 3)5.2 score on a scaleStandard Deviation 4.6
Group 2 (HearCARE Start at T2)Family Burden5 months (Time 1)3.9 score on a scaleStandard Deviation 2.9
Group 3 (HearCARE Start at T3)Family Burden15 months (Time 3)5.4 score on a scaleStandard Deviation 3
Group 3 (HearCARE Start at T3)Family Burden20 months (Time 4)5.9 score on a scaleStandard Deviation 3.7
Group 3 (HearCARE Start at T3)Family BurdenBaseline (Time 0)5.4 score on a scaleStandard Deviation 3
Group 3 (HearCARE Start at T3)Family Burden10 months (Time 2)5.6 score on a scaleStandard Deviation 3.3
Group 3 (HearCARE Start at T3)Family Burden5 months (Time 1)4.5 score on a scaleStandard Deviation 3.1
Group 3 (HearCARE Start at T3)Family Burden25 months (Time 5)5.4 score on a scaleStandard Deviation 2.8
Group 4 (HearCARE Start at T4)Family Burden15 months (Time 3)4.1 score on a scaleStandard Deviation 3.8
Group 4 (HearCARE Start at T4)Family Burden5 months (Time 1)4.2 score on a scaleStandard Deviation 3.7
Group 4 (HearCARE Start at T4)Family Burden10 months (Time 2)4.8 score on a scaleStandard Deviation 3.7
Group 4 (HearCARE Start at T4)Family Burden25 months (Time 5)4.6 score on a scaleStandard Deviation 3.9
Group 4 (HearCARE Start at T4)Family Burden20 months (Time 4)5.0 score on a scaleStandard Deviation 3.5
Group 4 (HearCARE Start at T4)Family BurdenBaseline (Time 0)4.7 score on a scaleStandard Deviation 3.6
Group 5 (HearCARE Start at T5)Family Burden20 months (Time 4)5.3 score on a scaleStandard Deviation 3.9
Group 5 (HearCARE Start at T5)Family Burden10 months (Time 2)4.8 score on a scaleStandard Deviation 3.8
Group 5 (HearCARE Start at T5)Family Burden5 months (Time 1)4.6 score on a scaleStandard Deviation 3.4
Group 5 (HearCARE Start at T5)Family Burden25 months (Time 5)4.4 score on a scaleStandard Deviation 3.6
Group 5 (HearCARE Start at T5)Family Burden15 months (Time 3)5.0 score on a scaleStandard Deviation 4.8
Group 5 (HearCARE Start at T5)Family BurdenBaseline (Time 0)4.9 score on a scaleStandard Deviation 3
p-value: 0.9695% CI: [-1.2, 1.14]Mixed Models Analysis
Secondary

Staff Satisfaction

Michigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction.

Time frame: Baseline, at 5, 10, 15, 20 and 25 months

Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).

ArmMeasureGroupValue (MEAN)Dispersion
Group 1 (HearCARE Start at T1)Staff SatisfactionBaseline (Time 0)2.1 score on a scaleStandard Deviation 1
Group 1 (HearCARE Start at T1)Staff Satisfaction5 months (Time 1)1.9 score on a scaleStandard Deviation 1
Group 1 (HearCARE Start at T1)Staff Satisfaction10 months (Time 2)1.7 score on a scaleStandard Deviation 0.8
Group 1 (HearCARE Start at T1)Staff Satisfaction15 months (Time 3)1.8 score on a scaleStandard Deviation 0.8
Group 1 (HearCARE Start at T1)Staff Satisfaction20 months (Time 4)1.8 score on a scaleStandard Deviation 1.1
Group 1 (HearCARE Start at T1)Staff Satisfaction25 months (Time 5)1.6 score on a scaleStandard Deviation 0.8
Group 2 (HearCARE Start at T2)Staff Satisfaction20 months (Time 4)1.5 score on a scaleStandard Deviation 0.8
Group 2 (HearCARE Start at T2)Staff Satisfaction25 months (Time 5)1.4 score on a scaleStandard Deviation 0.7
Group 2 (HearCARE Start at T2)Staff SatisfactionBaseline (Time 0)1.3 score on a scaleStandard Deviation 0.5
Group 2 (HearCARE Start at T2)Staff Satisfaction10 months (Time 2)1.1 score on a scaleStandard Deviation 0.3
Group 2 (HearCARE Start at T2)Staff Satisfaction15 months (Time 3)1.3 score on a scaleStandard Deviation 0.6
Group 2 (HearCARE Start at T2)Staff Satisfaction5 months (Time 1)1.9 score on a scaleStandard Deviation 0.8
Group 3 (HearCARE Start at T3)Staff Satisfaction15 months (Time 3)2.0 score on a scaleStandard Deviation 1
Group 3 (HearCARE Start at T3)Staff Satisfaction20 months (Time 4)1.9 score on a scaleStandard Deviation 1.1
Group 3 (HearCARE Start at T3)Staff SatisfactionBaseline (Time 0)1.6 score on a scaleStandard Deviation 0.8
Group 3 (HearCARE Start at T3)Staff Satisfaction10 months (Time 2)2.2 score on a scaleStandard Deviation 1.2
Group 3 (HearCARE Start at T3)Staff Satisfaction5 months (Time 1)1.6 score on a scaleStandard Deviation 0.7
Group 3 (HearCARE Start at T3)Staff Satisfaction25 months (Time 5)1.7 score on a scaleStandard Deviation 0.7
Group 4 (HearCARE Start at T4)Staff Satisfaction15 months (Time 3)1.7 score on a scaleStandard Deviation 0.8
Group 4 (HearCARE Start at T4)Staff Satisfaction5 months (Time 1)1.8 score on a scaleStandard Deviation 0.9
Group 4 (HearCARE Start at T4)Staff Satisfaction10 months (Time 2)1.4 score on a scaleStandard Deviation 0.5
Group 4 (HearCARE Start at T4)Staff Satisfaction25 months (Time 5)1.4 score on a scaleStandard Deviation 0.5
Group 4 (HearCARE Start at T4)Staff Satisfaction20 months (Time 4)1.4 score on a scaleStandard Deviation 0.6
Group 4 (HearCARE Start at T4)Staff SatisfactionBaseline (Time 0)2.1 score on a scaleStandard Deviation 1
Group 5 (HearCARE Start at T5)Staff Satisfaction20 months (Time 4)1.8 score on a scaleStandard Deviation 0.8
Group 5 (HearCARE Start at T5)Staff Satisfaction10 months (Time 2)1.7 score on a scaleStandard Deviation 0
Group 5 (HearCARE Start at T5)Staff Satisfaction5 months (Time 1)1.8 score on a scaleStandard Deviation 0.7
Group 5 (HearCARE Start at T5)Staff Satisfaction25 months (Time 5)1.9 score on a scaleStandard Deviation 0.8
Group 5 (HearCARE Start at T5)Staff Satisfaction15 months (Time 3)2.1 score on a scaleStandard Deviation 0.9
Group 5 (HearCARE Start at T5)Staff SatisfactionBaseline (Time 0)1.8 score on a scaleStandard Deviation 0.6
p-value: 0.1395% CI: [-0.07, 0.48]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026